非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.003201931844318733206432134319870.39
210.063289632683327900.46
单位质量响应值RSD%判断
3198.703259.441.34数据可信
供试品溶液-25112501批-多替诺雷-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17913-791321.98921.178.6121.9921.178.61
26384-638417.74017.74
38329-832923.14423.14
47783-778321.62721.63
57600-760021.11921.12
67696-769621.38621.39
10min117955-1795549.89349.164.5549.9349.194.55
216219-1621945.06945.10
318141-1814150.41050.45
417893-1789349.72149.76
518515-1851551.44951.48
617415-1741548.39348.43
15min122749-2274963.21563.881.5063.3364.001.50
222516-2251662.56762.67
323457-2345765.18265.30
423177-2317764.40464.52
523178-2317864.40764.53
622862-2286263.52963.64
20min125699-2569971.41271.480.9971.6471.710.99
225334-2533470.39870.61
325946-2594672.09872.33
425691-2569171.39071.62
526053-2605372.39672.62
625623-2562371.20171.42
30min128413-2841378.95479.661.0979.3080.011.10
228367-2836778.82679.15
328936-2893680.40780.76
428571-2857179.39379.74
529156-2915681.01881.37
628569-2856979.38779.73
45min130669-3066985.22385.810.8585.7086.280.85
230711-3071185.33985.80
330822-3082285.64886.13
430775-3077585.51785.99
531380-3138087.19887.68
630921-3092185.92386.40
60min131572-3157287.73288.961.2188.3589.581.21
231986-3198688.88289.48
331880-3188088.58889.22
431713-3171388.12488.74
532592-3259290.56691.20
632348-3234889.88890.50
极限132522-3252290.37290.900.7491.1491.670.74
232623-3262390.65291.40
332440-3244090.14490.92
432773-3277391.06991.84
533112-3311292.01192.79
632811-3281191.17591.94
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.072491862478022479082488542491832485870.28
210.072530702519422525060.32
单位质量响应值RSD%判断
24685.9025075.071.11数据可信
供试品溶液-25112501批-非布司他-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min162407-6240722.55321.878.9922.5521.878.98
250019-5001918.07618.08
365950-6595023.83423.83
462260-6226022.50022.50
561763-6176322.32122.32
660687-6068721.93221.93
10min1132899-13289948.02847.214.6548.0747.244.66
2119186-11918643.07343.10
3134870-13487048.74148.78
4132736-13273647.96948.01
5135312-13531248.90048.94
6128770-12877046.53646.57
15min1167238-16723860.43859.901.5360.5660.021.54
2160979-16097958.17658.28
3166918-16691860.32260.44
4167497-16749760.53260.65
5167105-16710560.39060.51
6164798-16479859.55659.67
20min1185428-18542867.01266.830.5767.2367.040.58
2183084-18308466.16566.36
3185707-18570767.11367.33
4185812-18581267.15167.37
5185123-18512366.90267.12
6184366-18436666.62866.84
30min1207100-20710074.84474.720.4975.1775.040.50
2205180-20518074.15074.46
3207759-20775975.08275.42
4207543-20754375.00475.33
5206954-20695474.79175.12
6205928-20592874.42074.74
45min1223609-22360980.81081.040.3481.2681.500.34
2224098-22409880.98781.42
3225112-22511281.35381.81
4223256-22325680.68281.14
5225024-22502481.32181.78
6224449-22444981.11481.56
60min1231915-23191583.81284.570.6284.4085.160.61
2234478-23447884.73885.31
3234452-23445284.72985.32
4233368-23336884.33784.93
5236237-23623785.37485.96
6233665-23366584.44485.03
极限1239171-23917186.43486.760.3987.1687.490.39
2240146-24014686.78687.50
3238800-23880086.30087.04
4240724-24072486.99587.73
5241239-24123987.18187.91
6240404-24040486.88087.60
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.003276132453329433250432861327040.67
210.063237932689325340.68
单位质量响应值RSD%判断
3270.403234.000.80数据可信
供试品溶液-25112502批-多替诺雷-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min17376-737620.34920.162.5420.3520.162.55
26973-697319.23819.24
37341-734120.25320.25
47440-744020.52620.53
57233-723319.95519.95
67484-748420.64720.65
10min117701-1770148.83545.924.7948.8745.964.79
215489-1548942.73242.76
315957-1595744.02344.06
416849-1684946.48446.52
516795-1679546.33546.37
617079-1707947.11947.15
15min123234-2323464.10061.712.4064.2161.822.40
221810-2181060.17160.27
321789-2178960.11360.22
422549-2254962.21062.32
522416-2241661.84361.95
622403-2240361.80761.92
20min125858-2585871.33970.361.0271.5670.581.03
225343-2534369.91870.12
325197-2519769.51569.72
425641-2564170.74070.96
525687-2568770.86771.08
625303-2530369.80870.02
30min128941-2894179.84478.840.8080.1979.180.80
228696-2869679.16879.49
328310-2831078.10478.43
428540-2854078.73879.07
528598-2859878.89879.23
628384-2838478.30878.64
45min130969-3096985.43984.940.5585.9185.400.56
230912-3091285.28285.73
330523-3052384.20984.66
430655-3065584.57385.04
530874-3087485.17785.64
630789-3078984.94385.41
60min132220-3222088.89187.980.7189.5188.580.71
232042-3204288.40088.99
331925-3192588.07788.67
431714-3171487.49588.10
531826-3182687.80488.41
631601-3160187.18387.79
极限132792-3279290.46989.740.4891.2390.480.49
232507-3250789.68290.42
332340-3234089.22289.96
432460-3246089.55390.30
532606-3260689.95690.71
632456-3245689.54290.29
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.072568352553592571632548592564392561310.39
210.072536162543892540020.22
单位质量响应值RSD%判断
25435.0525223.630.60数据可信
供试品溶液-25112502批-非布司他-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min161859-6185921.95821.463.0821.9621.463.08
256742-5674220.14220.14
360967-6096721.64121.64
460888-6088821.61321.61
560909-6090921.62121.62
661385-6138521.79021.79
10min1134377-13437747.70045.294.2647.7445.334.26
2120015-12001542.60242.64
3122517-12251743.49043.53
4128337-12833745.55645.59
5128609-12860945.65245.69
6131649-13164946.73146.77
15min1172167-17216761.11459.511.7561.2359.621.76
2164534-16453458.40558.51
3164256-16425658.30658.41
4168148-16814859.68759.80
5168298-16829859.74159.85
6168434-16843459.78959.90
20min1192167-19216768.21467.400.7968.4367.610.80
2188577-18857766.93967.14
3187993-18799366.73266.94
4190586-19058667.65267.86
5190273-19027367.54167.75
6189622-18962267.31067.52
30min1214471-21447176.13175.330.7176.4675.650.71
2211442-21144275.05675.37
3210143-21014374.59474.91
4213157-21315775.66475.99
5212276-21227675.35275.68
6211722-21172275.15575.48
45min1228377-22837781.06781.230.2681.5381.680.26
2229521-22952181.47381.91
3228754-22875481.20181.64
4229475-22947581.45781.91
5228874-22887481.24381.69
6228028-22802880.94381.39
60min1239195-23919584.90784.700.2385.5085.280.23
2238961-23896184.82485.40
3238569-23856984.68585.26
4238935-23893584.81585.40
5237893-23789384.44585.03
6238062-23806284.50585.09
极限1245040-24504086.98286.650.2887.7287.370.28
2244389-24438986.75187.47
3244036-24403686.62587.34
4244398-24439886.75487.48
5243147-24314786.31087.04
6243555-24355586.45587.18
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.003251732712329153232432698326330.69
210.063205632260321580.45
单位质量响应值RSD%判断
3263.303196.621.46数据可信
供试品溶液-25112503批-多替诺雷-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19485-948526.35025.9710.6226.3525.9710.62
27816-781621.71321.71
38928-892824.80324.80
49084-908425.23625.24
510661-1066129.61729.62
610111-1011128.08928.09
10min119854-1985455.15654.072.8055.2054.112.80
218467-1846751.30351.34
319658-1965854.61154.65
419205-1920553.35353.39
519774-1977454.93454.98
619822-1982255.06755.11
15min124056-2405666.82966.710.6766.9766.850.68
223760-2376066.00766.13
324109-2410966.97667.11
423920-2392066.45166.58
524018-2401866.72466.86
624226-2422667.30267.44
20min125955-2595572.10572.761.2172.3573.001.21
225920-2592072.00872.24
326580-2658073.84174.09
426223-2622372.84973.09
525903-2590371.96072.21
626559-2655973.78374.03
30min128288-2828878.58679.751.8278.9580.121.81
229552-2955282.09882.45
329054-2905480.71481.08
428642-2864279.56979.93
528132-2813278.15378.52
628583-2858379.40679.78
45min130238-3023884.00384.611.1584.5085.111.14
230741-3074185.40185.89
330745-3074585.41285.91
430690-3069085.25985.75
529869-2986982.97883.48
630454-3045484.60385.11
60min131212-3121286.70987.191.4287.3587.831.41
231559-3155987.67388.30
331630-3163087.87088.51
431764-3176488.24388.88
530560-3056084.89885.54
631580-3158087.73188.38
极限131758-3175888.22688.891.2189.0189.681.20
232125-3212589.24690.02
332014-3201488.93789.73
432294-3229489.71590.50
531368-3136887.14387.92
632428-3242890.08790.88
非布司他多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101278-202405对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.072531442547402545822524072526812535110.43
210.072476542503642490090.77
单位质量响应值RSD%判断
25174.8824727.811.27数据可信
供试品溶液-25112503批-非布司他-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min181302-8130229.29928.1911.3529.3028.1911.35
263631-6363122.93122.93
375128-7512827.07427.07
476666-7666627.62827.63
590077-9007732.46132.46
682598-8259829.76629.77
10min1153840-15384055.43954.133.2855.4954.183.28
2141102-14110250.84950.89
3149970-14997054.04554.09
4149090-14909053.72853.77
5153766-15376655.41355.47
6153459-15345955.30255.35
15min1180998-18099865.22664.830.8465.3764.970.85
2177446-17744663.94664.07
3179960-17996064.85264.99
4179028-17902864.51664.65
5180359-18035964.99665.14
6181677-18167765.47165.61
20min1196135-19613570.68170.390.4770.9370.630.48
2194491-19449170.08970.32
3195037-19503770.28670.53
4194555-19455570.11270.35
5194946-19494670.25370.51
6196750-19675070.90371.15
30min1211540-21154076.23376.820.6776.6077.180.67
2213447-21344776.92077.27
3214489-21448977.29577.66
4212923-21292376.73177.09
5211636-21163676.26776.64
6214982-21498277.47377.84
45min1230418-23041883.03682.520.7583.5383.020.74
2230655-23065583.12183.60
3227510-22751081.98882.48
4229324-22932482.64283.13
5226344-22634481.56882.07
6229723-22972382.78583.28
60min1237251-23725185.49885.630.8986.1386.260.88
2237782-23778285.69086.30
3238733-23873386.03286.66
4239054-23905486.14886.77
5233603-23360384.18484.82
6239263-23926386.22386.86
极限1241993-24199387.20787.530.7087.9888.300.69
2244015-24401587.93688.69
3242435-24243587.36688.14
4241891-24189187.17087.94
5241257-24125786.94287.72
6245762-24576288.56589.35
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